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Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
Summary
Responsible for building and implementing processes for end-to-end operational feasibility deliverables at the disease, program, study, country, and site levels. This position is required to work within a team focused on process, data/insight packages, outsourcing, and innovation. Depending on business needs this position may take leadership and/or will participate in process improvement initiatives that are at the intersection of technology, process and analytics that may directly or indirectly support Feasibility and/or additional related areas (e.g study start up, protocol development) to ensure Global Clinical Operations (GCO) goals are met.
Responsibilities:
- Execute on the build, improvement, and oversight of end-to-end operational feasibility processes.
- Ensure processes are effective, streamlined and are by design initiated at the optimal time in the clinical drug development process.
- Provide oversight to ensure such processes are adhered to consistently and exceptions are appropriately managed.
- Ensure feasibility related roles and responsibilities within external partners (e.g. CROs, specialty Vendors) and internal to Daiichi Sankyo (e.g. Regional Site Engagement Managers) are well defined, clear and aligned.
- Identify, monitor, analyze and appropriately act on key quality and performance indicators for process oversight/adherence, and measure of success to ensure maximum impact and efficiency in overall feasibility processes and output.
- Drives process related improvement in process space. This includes gathering cross functional feedback to support significant process improvement efforts related to process space.
- Supports design and development of framework for data and insight packages.
- Development and timely delivery of appropriate data and insight packages (with support from analyst staff as appropriate) to program and study teams to support all relevant Governance and planning meetings.
- Own the engagement with program and study teams to support the build out of various what if scenarios and modelling for increased transparency on impact to clinical trial operational designs, timelines, and operational costs.
- Identify opportunities to effectively scale processes and staff in support of building such data and insight packages.
- Proactively reaches out and build relationship with key program and study staff at clinical development and operational team levels to drive adoption of fit for purpose strategies and tactics to support operational design optimization.
- Identify innovative approaches, platforms, best practices, tools and data strategies to support best in class feasibility inputs to Daiichi Sankyo’s clinical programs and studies.
- Continually evaluate industry landscape and lead identification assessment of innovative approaches
- identify, build and manage effective relationships with academic, corporate and vendor consortiums.
- Provide oversight and be one of the key subject matter experts (SMEs) on Daiichi Sankyo's existing feasibility related portfolio of platforms, tools and systems.
- Collaborate effectively with other areas within the business such as IT and RD Excellence as it relates to existing data and analytics services and capabilities.
People Management:
- May manage staff which would include oversight, training and mentoring of employee and/or contractor-based staff/analysts to support the overall end to end feasibility processes and oversight, and timely and consistent data and insight package development.
Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications: (from an accredited college or university)
- Bachelor's Degree 7 years relevant experience is required required.
- Master's Degree 5 years relevant experience is required.
- PharmD 3 years relevant experience is required.
- PhD 3 years relevant experience is required Experience Qualifications
- 7 or More Years clinical operations experience in either study feasibility, and/or study design optimization and/or clinical operations project management preferably with a sponsor company at a global level. Prior investigator site and/or monitoring experience is advantageous.
- Proven track record of providing feasibility related services and value to organization(s)
- Demonstrated success in working cross-functionally in a global matrix organization; minimum 2 years of experience in managing or supporting global cross-functional processes and contributed towards driving processes and oversight.
Travel
- Ability to travel up to 10% Remote by design. may require some travel (domestic or global)
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
